1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) -  By email communication to Study Investigators: Dr Shivaprasad S Goudar (sgoudar@jnmc.edu), Dr S M Dhaded (drdhadedsm@gmail.com), Dr. Nitya Wadhwa (nitya.wadhwa@thsti.res.in), Dr. Sugandha Arya (sugandha_arya@hotmail.com) and members of WHO Trial Coordinating Unit: Dr. Tarun Dua (duat@who.int) and Dr Ayesha de Costa (deay@who.int)


6. For how long will this data be available start date provided 01-06-2028 and end date provided 31-05-2033?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Executive Summary:

Rationale:

Antenatal corticosteroids (ACS) are crucial for improving survival in early preterm birth (PTB). Their effects in late PTB are ambiguous, offering respiratory benefits but increasing hypoglycemia risk. The short-term effects are being investigated in a large scale WHO-coordinated study in LMICs including India. However, studies report conflicting evidence on its impact on neurodevelopment, indicating the need for a comprehensive follow-up of infants in the trial.

Novelty:

Multicenter study across India using mixed methods leveraging robust trial framework evaluating dose-related long-term neurodevelopmental and economic effects of ACS in late PTB.

Objective:

Evaluate global neurodevelopment at 33+3 months of age, as measured by the GSED-DAZ (Z-score), in children exposed antenatally to a regimen of dexamethasone (4x6mg IM q12h) or betamethasone (4x2mg IM q12h) given to their mothers during late preterm period. Generate evidence on risk of neurodevelopmental impairment, death/severe illness, equity impact, and financial risk protection with ACS use in late PTB.

Methods:

Follow-up study within robust trial (ACTION III) framework; will enroll 2000 participants from 2 sites and 5 hospitals in India. Participants are infants born to mothers at high risk of late PTB, who have received antenatal dexamethasone (4x6mg IM q12h) or betamethasone (4x2mg IM q12h) or placebo. Infants will be followed up longitudinally until 33+3 months of age to assess neurodevelopment across multiple developmental domains. The primary outcome of global neurodevelopment will be measured on a continuous scale using the General Scale of Early Development (GSED) tool. Neurodevelopmental impairment, a secondary outcome will be measured as a composite outcome of any of cognitive developmental impairment, neuro-motor impairment, hearing impairment, behavioral impairment, communication impairment, vision impairment, and epilepsy by the age of 33+3 months. The data will be collected and managed electronically and will be analyzed in an intention-to-treat analysis.

Expected outcome:

Evidence shaping clinical guidelines and policy in India regarding ACS use in late PTB, including cost analysis for intervention scaling. Contribute to global analysis and guidance on ACS for late preterm.